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PharmaCompass offers a list of Levobunolol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Levobunolol manufacturer or Levobunolol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levobunolol manufacturer or Levobunolol supplier.
PharmaCompass also assists you with knowing the Levobunolol API Price utilized in the formulation of products. Levobunolol API Price is not always fixed or binding as the Levobunolol Price is obtained through a variety of data sources. The Levobunolol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vistagan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vistagan, including repackagers and relabelers. The FDA regulates Vistagan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vistagan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Vistagan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vistagan supplier is an individual or a company that provides Vistagan active pharmaceutical ingredient (API) or Vistagan finished formulations upon request. The Vistagan suppliers may include Vistagan API manufacturers, exporters, distributors and traders.
click here to find a list of Vistagan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vistagan DMF (Drug Master File) is a document detailing the whole manufacturing process of Vistagan active pharmaceutical ingredient (API) in detail. Different forms of Vistagan DMFs exist exist since differing nations have different regulations, such as Vistagan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vistagan DMF submitted to regulatory agencies in the US is known as a USDMF. Vistagan USDMF includes data on Vistagan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vistagan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vistagan suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Vistagan Drug Master File in Japan (Vistagan JDMF) empowers Vistagan API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Vistagan JDMF during the approval evaluation for pharmaceutical products. At the time of Vistagan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Vistagan suppliers with JDMF on PharmaCompass.
A Vistagan written confirmation (Vistagan WC) is an official document issued by a regulatory agency to a Vistagan manufacturer, verifying that the manufacturing facility of a Vistagan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vistagan APIs or Vistagan finished pharmaceutical products to another nation, regulatory agencies frequently require a Vistagan WC (written confirmation) as part of the regulatory process.
click here to find a list of Vistagan suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Vistagan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vistagan API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Vistagan as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Vistagan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vistagan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vistagan suppliers with NDC on PharmaCompass.
Vistagan Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Vistagan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Vistagan GMP manufacturer or Vistagan GMP API supplier for your needs.
A Vistagan CoA (Certificate of Analysis) is a formal document that attests to Vistagan's compliance with Vistagan specifications and serves as a tool for batch-level quality control.
Vistagan CoA mostly includes findings from lab analyses of a specific batch. For each Vistagan CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Vistagan may be tested according to a variety of international standards, such as European Pharmacopoeia (Vistagan EP), Vistagan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vistagan USP).
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